Efficacy of CBT-I and Lemborexant Medication for Different Subtypes of Chronic Insomnia
ConditionInsomnia Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLaval University
About this trial
The primary aims of this study is to contrast the effectiveness of CBT-I and pharmacotherapy (lemborexant) compared to placebo on sleep and mental health outcomes in people with insomnia disorder and anxiety/depressive symptoms. In addition, the study will evaluate whether insomnia phenotypes (i.e., +/- 6hrs of sleep) at baseline moderate the effectiveness of the intervention on both sleep and mental health outcomes.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 years of age or older at the time of enrolment
Meeting Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for insomnia disorder (Duke Sleep Interview), with total Insomnia Severity Index (ISI) score > 10, and score ≥ 2 on either the interference or distress item
Minimal symptoms of anxiety and/or depression with Patient Health Questionnaire (PHQ-9) > 4 and/or Generalized Anxiety Disorder (GAD-7) > 4
Ability to read and understand French or English
Disqualifiers
Presence of a lifetime diagnosis of any psychotic or bipolar disorder
Untreated psychiatric disorder (e.g., major depression) or risk for suicide
Substance/alcohol use disorder within the past year
Any life-threatening or progressive medical illness (e.g., cancer, chronic obstructive pulmonary disease) or neurological degenerative disease (e.g., dementia)
Trial design
Design model
Parallel
Treatments tested in this trial
Cognitive Behavioral Treatment for Insomnia (CBT-I)
BehavioralParticipants in this treatment group will receive CBT-I. CBT-I sessions will occur weekly for the first 4 sessions and biweekly for the last 2 sessions (treatment phase is thus 8 weeks). : Graduate level students in clinical psychology will serve as therapists for this project.
Lemborexant
DrugParticipants assigned to this group will be prescribed 5 to 10 mg of lemborexant to be taken at bedtime in 5 mg capsules. Lemborexant (Dayvigo) is a Dual Orexin Receptor Antagonist approved by Health Canada for the treatment of adult with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance. Pharmacy staff will package medications for each participant in a generic bottle labeled with the participant's ID code and treatment dates (identical for the lemborexant and placebo arms). Six consultation visits will be conducted during the 8-week treatment phase to monitor treatment response and drug side effects. The starting dose will be 5 mg with titration to 10 mg if needed (i.e., based on clinical response and tolerability) following the first week.
Placebo
DrugParticipants assigned to this group will be prescribed 5 to 10 mg of placebo to be taken at bedtime in 5 mg capsules identical to lemborexant. Pharmacy staff will package medications for each participant in a generic bottle labeled with the participant's ID code and treatment dates (identical for the lemborexant and placebo arms). Six consultation visits will be conducted during the 8-week treatment phase to monitor treatment response and drug side effects. The starting dose will be 5 mg with titration to 10 mg if needed (i.e., based on clinical response and tolerability) following the first week.
Treatment groups
90 Participants
are divided into 3 treatment groupsGroup A: Cognitive Behavioral Treatment for Insomnia (CBT-I)Experimental treatment 1 intervention
Group B: Lemborexant medicationExperimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Insomnia Symptom Severity
Insomnia symptoms will be measured by the Insomnia Severity Index (ISI). The ISI is a self-report questionnaire evaluating seven dimensions of insomnia-severity of sleep onset, sleep maintenance, early morning awakening problems, sleep dissatisfaction, interference of sleep difficulties with daytime functioning, noticeability of sleep problems by others, and distress caused by sleep difficulties. Each item is rated on a 0 to 4 scale and the total score ranges from 0 to 28, with a higher total score suggesting more severe insomnia symptoms. An ISI score \< 8 will be used to define remission. Treatment response will be defined at each assessment as a reduction of 8 points or more on the ISI compared with the baseline score.
Time frame
Baseline, during treatment period (weeks 0-8), at the end of the 2-week post-treatment and 6-month follow-up.Secondary outcomes
1
Sleep onset latency from sleep diary
Mean sleep onset latency per night in minutes from sleep diary.
Time frame
Nightly during 2-week pre-treatment, treatment period (weeks 0-8), 2-week post-treatment and 6-month follow-up.2
Wake after sleep onset from sleep diary
Mean wake after sleep onset per night in minutes from sleep diary.
Time frame
Nightly during 2-week pre-treatment, treatment period (weeks 0-8), 2-week post-treatment and 6-month follow-up.3
Total sleep time from sleep diary
Mean total sleep time per night in minutes from sleep diary.
Time frame
Nightly during 2-week pre-treatment, treatment period (weeks 0-8), 2-week post-treatment and 6-month follow-up.4
Sleep efficiency from sleep diary
Mean sleep efficiency per night in percentage from sleep diary.
Time frame
Nightly during 2-week pre-treatment, treatment period (weeks 0-8), 2-week post-treatment and 6-month follow-up.Other outcomes
1
Cognitive performance
Changes in cognitive performance measured by Cognitive Failures Questionnaire 2.0 (CFQ 2.0) will serve as an exploratory outcome. The CFQ 2.0 is a 15-item questionnaire asking respondents to rate the frequency with which they make minor mistakes (e.g., forgetting to take their keys, calling people by the wrong name). Scores range from 0 to 60, with higher scores indicating greater frequency of cognitive failures.
Time frame
Baseline and at the end of the 2-week post-treatment.Sponsors and contacts
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Laval University
Lead sponsor
Toronto Metropolitan University
Collaborator
The Royal Ottawa Mental Health Centre
Collaborator
Source ClinicalTrials.gov